Needleless Luer activated medical connector

ABSTRACT

A medical fluid flowline connector comprised of axially aligned relatively rotatable male and female Luer parts and an axially compressible elastomeric seal therebetween includes an elastomeric stopper in the female Luer, the stopper having a swabbable end urged outwardly of the female Luer. The stopper is guided on an axially extending elongated flow conducting insert which has an end which contacts a deformable slit in the swabbable end of the stopper to ensure deformation and opening of the slot as a male Luer at the end of a fluid flowline is pushed against the stopper. The stopper skirt is deformed and displaced into annular space between the female Luer and the insert, the stopper having bellows like walls which engage the female Luer and insert.

BACKGROUND OF THE INVENTION AND PRIOR ART

[0001] The present invention relates to connectors for use in medicalflow lines for blood transfer, intravenous medication and nutritionalsupply, and the like. In accord with usual medical terminology, theconnector may be referred to as having distal and proximal endsrespectively designating the ends of the connector which are ordinarilypositioned nearest and farthest from the patient.

[0002] U.S. Pat. No. 5,273,533 issued Dec. 28, 1993 and U.S. Pat. No.5,306,243 issued Apr. 26, 1994 to Bonaldo each disclose a medicalconnector having an elastomeric element in the form of a septum or fluidbarrier disposed in a two part plastic housing. The septum is pierced bya pointed cannula in the connector when making the connection to thefluid flowline. Disconnection of the flow line allows the elastomer tore-seal the connector. Repeated usage of such connectors may cause theconnector to leak or become contaminated with particulate material suchas particles which may detach from the septum. Current Food and DrugAdministration (FDA) requirements dictate that medical flowlineconnectors not remain connected for more than 24 hours at a time. Forthis reason, repeated disconnection of the flowlines from the connectorand decontamination of the connector and flowlines, as by swabbing withalcohol, is at least a daily occurrence. Thus, these connectors may beactuated or cycled many times and must remain leak free and reliablyavoid introduction of contaminants such as cotton fibers from swabs usedto clean the connectors into the flowline.

[0003] Medical connectors which use resilient flow barriers which arerepeatedly pierced during use of the connector become more subject tofluid leakage with increased actuation cycles, particularly if connectedin an infusion pump line which may subject the connector to pressures ashigh as 27 psi. U.S. Pat. No. 5,947,954 issued Sep. 7, 1999 to Bonaldo,the teachings of which are incorporated herein by reference, discloses aneedleless connector which is addressed to the above concerns whichincludes attached relatively rotatable male and female Luer connectorparts with an eccentrically positioned flow passageway at the inner endof the female Luer connector. A removable plastic plug, permanentlyattached to the connector by a strap, and which fulfills the function ofa cleansing swab for the female Luer connector is also provided as anoptional feature.

[0004] Although the removable plug when properly used closes the femaleLuer when the female Luer is not connected to a flowline, it has beenfound in practice that additional manipulation of the plug is requiredfor proper use and that the plug can inadvertently become dislodgedleaving the female Luer open to atmosphere and possible contamination.Accordingly, a more reliable and easy to use swabbable stopper for thefemale Luer part of the connector has been developed which alwaysremains in proper position yet which also permits easyconnection/disconnection of the male Luer end of a flowline to/from theconnector valve is disclosed and claimed in a more recent U.S. Pat. No.6,364,869 issued Apr. 2, 2002 to Bonaldo, the full teachings of whichare also incorporated herein by reference. This stopper has an exteriorend which essentially completely closes the otherwise open end of thefemale Luer when the connector is not in use to prevent introduction offibers or other contaminants into the flow path in the connector.However, since fluid flow takes place along the outside of a stopperguide post mounted in the connector, it has been found that fluid mayremain in the annular space between the post and inside wall of theswabbable stopper.

[0005] There remains a need to provide a further improved medicalconnector which includes a female Luer end having a swabbableelastomeric stopper which still further reduces the likelihood ofcontaminant entry to the fluid flow path. Also, there remains a need fora connector which has readily observable indicators thereon to enablethe user to determine if the relatively rotatable parts of the connectorare positioned to place the connector in the open or closed position.

SUMMARY OF THE INVENTION

[0006] Disclosed herein is a medical connector having a longitudinalaxis and interconnected axially aligned relatively rotatable male andfemale Luer parts aligned to provide a housing whereby relative rotationof said parts opens and closes a fluid flow path through the connector,the parts being configured for connection to external male and femaleLuer flowlines. The device includes a fluidic channel insert, alsoreferred to herein as a flow conducting insert, which is non-rotatablysupported in the female Luer part. The insert has an internal fluidpassageway extending from a first axially aligned end to a second end,said second end being offset from the connector axis. A compressibleseal is positioned in the male Luer part and abuts the second end of theinsert, the seal having a flow passageway extending between a firstaxially offset end at the second end of the insert to an axially alignedsecond end, such that said ends of said flow passageways in abuttingends of the insert and seal may be aligned to open a fluid flow paththrough the connector. An elastomeric stopper is mounted over theinsert, the stopper having a swabbable end providing a deformablenormally closed opening which may be opened when the swabbable end ofthe stopper is pushed over the end of the insert by an external maleLuer received in said female Luer part. The stopper has an annularaxially collapsible skirt engaged with the female Luer part and insert.

[0007] A swabbable stopper having a unique configuration is alsodisclosed and claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In the accompanying drawings:

[0009]FIG. 1 comprises an exploded perspective view of the presentlypreferred embodiment of a medical connector according to the presentinvention including a contamination cap for a male Luer part;

[0010]FIGS. 2A and 2b comprises a longitudinal cross-section viewsshowing the medical connector of FIG. 1 with a swabbable stopper at theend of the female Luer part and with the connector in the closedposition;

[0011]FIG. 3A is a view like FIG. 2A with the stopper end displaced fromthe FIG. 2A position by an external male Luer in a flowline and showingthe connector in the open position;

[0012]FIG. 3B is a portion of FIG. 3A to a substantially enlarged scale;

[0013]FIG. 4 is a cross-sectional elevation of a female Luer housingpart;

[0014]FIG. 5 is a left end view of the female Luer housing part;

[0015]FIG. 6 is a right end view of the female Luer housing part;

[0016]FIG. 7 is a cross-sectional elevation of a male Luer housing part;

[0017]FIG. 8 is a left end view of the male Luer housing part;

[0018]FIG. 9 is a right end view of the male Luer housing part;

[0019]FIG. 10 is a cross-sectional elevation view of the swabbablestopper;

[0020]FIG. 11 is a left end view of the stopper;

[0021]FIG. 12 is a right end view of the stopper;

[0022]FIG. 13 is a cross-sectional elevation view of the flow conductinginsert;

[0023]FIG. 14 is a left end view of the insert;

[0024]FIG. 15 is a right end view of the insert;

[0025]FIG. 16 is a perspective view of a seal;

[0026]FIG. 17 is a left end view of the seal; and

[0027]FIG. 18 is a right end view of the seal.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0028] The medical connector 10 in which the present invention is usedcomprises essentially a five part connector comprising a housing formedby a male Luer configured part 20 connected to a female Luer configuredpart 30 with a cylindrical resilient seal 40 the outer edges of whichare compressed between a seat valve 22 formed at the end wall in themale Luer part 20 and an end wall 32 of the female Luer part 30. Themale Luer part 20 and female Luer part 30 are aligned on a commonlongitudinal axis and are rotatable with respect to each other throughan angle of preferably about 180° around the longitudinal axis toactivate and deactivate the connector by opening and closing flowpassageway through the connector. The female Luer part 30 includes acollar 31 having a face which abuts an end face of the male Luer part20, preferably along a transverse or radial plane. The collar 31functions to block ingress of fluid which may be spilled duringdisconnection of an external male Luer 100 axially between the facingportions of the male and female Luer parts 20, 30 since any spilledfluid ordinarily contacts the left end or side (as viewed in thedrawings) of the female Luer 30. The Exteriorly exposed surfacesadjacent the abutting faces are provided with visible or tactile indiciasuch as arrows 33, 43 which may be aligned by relative rotation of thefemale and male Luer parts 20, 30 to indicate the activated anddeactivated, i.e., the full open and closed positions of the connector.

[0029] A longitudinally extending rib 37 inside the male Luer part 30slides along a cam surface on the exterior of the right end of thefemale Luer part 30 and snaps into one of two axially extending camgrooves 27 on the exterior surface of the right end of the female Luerpart when the Open and Closed indicia 33, 43 are aligned at the fullopen and full closed positions of the connector. The grooves 27 andfinger 37 are preferably configured as shown in FIGS. 6 and 8 withcurved portions bounded by flat generally radially extending sides atthe ends of the curved portions to assure proper full open and fullclosed relative positioning of the parts 20, 30. A concave grippingsurface 21 on the male Luer part 20 may include elongated indentationsor other roughening to facilitate fingertip gripping of the connector.

[0030] As seen in FIGS. 1-3 and 7-9, the male Luer part 20 includes aninternal flow passageway 24 in a frusto-conical Luer tapered maleextension 26 and an internally threaded skirt 28 for connection to anexternal female slip or lock Luer in a flowline. The female Luer part 30has an internal frusto-conical Luer taper at its left end as seen in thedrawings and is also configured as a lock Luer externally threaded at34; however, either or both of the Luer parts 20, 30 can be configuredinstead as a slip or as a threaded lock Luer part. As shown, it will beapparent that the female Luer 30 is configured so that it may receiveeither an external male lock Luer or an external male slip Luer to makethe fluid connection. Similarly, internal threads 29 are provided insidethe skirt 28 of the male Luer part 20 so that it can be readilyconnected to either an external female lock Luer or an external femaleslip Luer.

[0031] The fluid flow passageway 24 in the male Luer part 20 extendslongitudinally from the male extension part 26 to the valve seat 22. Thefemale Luer part 30 shown in FIGS. 1-3 and 4-6, has an axially extendinginternal cavity 36 which may have an end portion 38 of non-circularconfiguration, for a purpose to be described.

[0032] The seal 40 (see FIGS. 16-18) has a generally cylindrical shapewith a fluid flow passageway 44 extending from an axially aligned end 46in fluid communication with passage 24 to an off-center positioned end48. The seal 40 is made of a firm but compressible elastomer, Preferablysilicone, the peripheral edge of which is preferably partiallycompressed between the valve seat 22 and the end wall 32 of the femaleLuer housing during assembly of the valve seal. The seal 40 has at leastone and preferably three axially extending grooves 43 on its annularsurface which mate with axially extending ribs 23 (FIG. 8) in the maleLuer part 20 to non-rotatably position the seal 40 in the male Luer part20. A longitudinally extending locating groove 45 is also provided onthe annular surface of the seal 40 so that the seal 40 may be insertedinto the male Luer part 20 along the finger 37.

[0033] A male end Luer contamination cap 50 which may be made ofpolyethylene plastic, may be provided for enclosing the extension 26 ofthe medical connector during shipment or when not in use.

[0034] As seen in FIGS. 10-12, a swabbable elastomeric stopper 60 havinga normally closed end 62 and a depending corrugated skirt 64 is slidablymounted in the female Luer part 30 to normally close the open endthereof. A transversely extending slit 66 is provided through thenormally closed end 62 of the elastomeric stopper 60 so that the slitcan be opened when a male Luer end 102 of an external lock Luer 100(FIG. 3A) engages the end 62 to push it over the end of a flowconducting insert 90 (to be described) when a flowline connection ismade to the connector. It will be understood that the slit 66 may be asingle transversely extending slit or two or more slits in form of across or any other functionally equivalent configuration such that thenormally closed end 62 of the stopper 60 may be displaced as desired bythe male Luer end 102 when a flowline connection is made. The stopper 60also has an annular collar 68 which slidably engages the interiorannular wall of the cavity 36 in the female Luer part 30 and acylindrical end 69 which engages and seals off between the inside of thefemale Luer and the exterior of the insert 90 which also functions as astopper guide.

[0035]FIGS. 13-15 show the fluidic channel insert or fluid conductinginsert 90, which may be made of polycarbonate, polypropylene,polyethylene or the like. The insert 90 may be integrally formed asshown or of multi-piece construction with a rigid or axially collapsiblelumen having a central flow passageway 92. Axial collapsibility of theinsert 90 is preferably provided by making the insert 90 ofpolypropylene or polyethylene with flexible corrugations 98 near theheel 96 of the insert 90. The corrugations 98 are not consideredessential but, if provided, permit slight axial collapsibility of theinsert 90 if contacted during activation by the end of an external maleLuer 100. This avoids force transmission by the insert 90 and undesireddeformation of the seal 40. Preferably the insert 90 is rounded at itsleft end as seen in the drawings for opening the slit 66 without damage.The flow passageway 92 axially extends from the left end of the insert90 to an offset opening 94 in an end which provides a seat for theswabbable stopper 60, the seat being hereinafter referred to as a heel96 due to its non-circular configuration shown in the drawings, at theother end of insert 90. The heel 96 is non-rotatably positioned innon-circular end portion 38 of the internal cavity 36 in the female Luerpart 30 and is preferably restrained from axial sliding relative to thefemale Luer part 30 by an interference or press fit. Other complementarynon-circular configurations of the heel 96 and end portion 38 can ofcourse be chosen instead of the heel configuration depicted and thoseskilled in the art will appreciate that non-circular configurations,while preferred, are not essential.

[0036] Fluid flow is conducted through the connector from an externalfluid flowline through the normally closed slit or slits 66 in the endwall 62 of the stopper which are displaced to the open position byengagement of the end wall 62 with an external male Luer 100, the end102 of which pushes the end 62 of the stopper 60 to the right as bestshown in the enlarged scale FIG. 3B so that the end of the insert 90opens the slit or slits 66 allowing fluid flow axially through the flowpassageway 92 in the insert 90 to the offset opening 94, then throughthe passageway 44 in the elastomeric valve element 40 to the passageway24 in the male Luer extension 26.

[0037] The resiliency and configuration of the skirt 64 of the swabbablestopper 60 are selected such that, during insertion of the external maleLuer 100 into the female Luer part 30, the end 102 of an external maleLuer 100 first engages the end wall 62 of the stopper which in turn ispushed over the rounded end of the insert 90 with the end wall 62folding and compressing between the end 102 of the external male Luerand the insert 90 to prevent fluid entry into the annular space betweenthe stopper 60 and the insert 90 as seen in FIG. 3A. Note that the endof the external male Luer 100 also engages the end 62 of the stopper 60to prevent fluid leakage to annular space between the stopper 90 andinterior wall of the female Luer part 30. The bellows portion of theskirt 64 between the collar 68 and the open end 69 of the skirt iscompressed in the annular space between the inside wall of the femaleLuer part 30 and the outside wall of the insert 90 by engagement of atleast some of the pleats of the bellows with the confining walls. Itwill be noted from viewing FIGS. 2A and 2B that the right end of thestopper 60 is also engaged with both the inside wall of the female Luerand the outside of the insert even when no flowline connection is madeand when the end wall 62 of the stopper is flush with the end of thefemale Luer 30.

[0038] It will also be noted that the stopper collar 68 preferablyaxially engages an internally projecting stop shoulder 35 inside thefemale Luer part 30 with some axial compression of the stopper skirt 64to provide a slight pre-load, and that the open end 64 of the skirtcontinuously engages and is resiliently seated against the heel 96 onthe insert 90 to retain the swabbable stopper in position. Also, thestopper 60 can be retained in position in the female Luer in any othersuitable fashion, for example by adhesive bonding to the heel 96 of theinsert 90 in which instance the skirt collar 68 and abutting shoulder 35in the female Luer are unnecessary.

[0039] Axial pressure which may be exerted on the insert 90 duringconnection by the external male Luer 100 may slightly move the insert tothe right as seen in FIG. 3 if the insert 90 is slidably fitted into thefemale Luer. This may serve to further compress the seal 40 whose outeredge preferably has already been slightly compressed by the end wall 32of the female Luer part 30 during assembly into the male Luer part 20.This compression of the seal may be avoided by use of the corrugations98 on the insert 90 as described above. The Luer parts 20, 30 arepreferably connected together by a snap fit provided by a mating annulargroove and collar depicted at 29. The stopper skirt 64 may have what isdescribed as a bellows or accordion like configuration as shown or itmay be of sine wave or any other functionally equivalent configurationsuitable for its intended purpose.

[0040] In the deactivated or closed position of the connector seen inFIGS. 2A and 2B, the bellows configuration of the skirt 64 of thestopper 60 urges the stopper end 62 outwardly of the female Luer part 30so that the outer surface of the normally closed end 62 of the stopper60 is substantially aligned or flush with the outer end of the femaleLuer part 30. This position is assured by provision of the skirt collar68 and its engagement with the stop shoulder 35 in the female Luer part30 at the positions shown. This permits easy swabbing of the stopperwhenever the flowline is disconnected from the connector and prior tothe making of a new connection thereto.

[0041] Needleless medical connectors constructed as above describedeliminate exposure to diseases such as hepatitis and HIV caused byneedle sticks and are suitable in various medical flow lines lowpressure gravity drips as well as highly pressurized fluid flow linesdue to the relatively straight fluid flow path through the connectorwhich substantially eliminate sharp bends and other internal flowrestrictions in the fluid flow passageways 92, 94, 44, 24. The connectorcan therefore be safely used for gravity blood transfusions withoutconcern that pressurization induced by an infusion pump may degradedelicate blood cells.

[0042] All dead annular space between the female Luer part 30 and theswabbable stopper 60 and between the swabbable stopper and the lumen ofthe insert 90 is sealed from fluid entry by engagement of the walls ofthe stopper 60 and the adjacent parts. This feature results inminimization of potential infections resulting from solid and bacterialcontaminants from fluid which may collect or stagnate in dead space aswell as reduction in the amount of fluid, such as expensive medication,required to prime the connector prior to activation since only theinternal passageways 92, 94 in the connector need be filled with primingfluid.

[0043] Negative pressure or bolus suck back upon disconnection of theexternal male Luer 100 is prevented simply by ensuring that the male andfemale Luer parts have been rotated to the Closed position prior todisconnection.

[0044] The connector may be made of clear plastic materials to enablevisualization of the flow path and the parts may be readily injectionmolded and assembled without the use of ultrasonic welding or adhesives,swaging or additional fasteners of any kind.

[0045] While the foregoing constitutes a complete description of theinvention, it will be appreciated by persons skilled in the art thatchanges and modifications of an obvious nature can be made from theillustrated embodiment and that such changes and modifications areconsidered within the scope of protection which is to be evaluatedsolely with respect to the attached claims.

1. A medical connector having a longitudinal axis and interconnectedaxially aligned relatively rotatable male and female Luer parts forminga housing whereby relative rotation of said parts opens and closes afluid flow path through said connector, said parts being configured forconnection to external male and female Luer flowlines; a flow conductinginsert non-rotatably affixed in said female Luer part, said inserthaving an internal fluid passageway extending from a first axiallyaligned end to a second end, said second end being offset from saidaxis; a compressible seal in said male Luer part, said seal abuttingsaid second end of said insert and having a flow passageway extendingbetween a first axially offset end at said second end of said insert toan axially aligned second end, such that said ends of said flowpassageways in abutting ends of said insert and seal may be aligned toopen said flow path; and an elastomeric stopper on said insert, saidstopper having a swabbable end providing a deformable normally closedopening which may be opened by pushing said swabbable end over saidinsert by an external male Luer received in said female Luer part, saidstopper having an annular axially collapsible skirt engaged with saidfemale Luer part and said insert.
 2. The medical connector of claim 1,wherein said first end of said insert is rounded to facilitate openingof said normally closed opening.
 3. The medical connector of claim 2,wherein in said insert includes a seat engageable with said second endof said skirt.
 4. The medical connector of claim 3, further comprisingrelatively engageable stop surfaces on said skirt and said female Luerpart to axially retain said skirt in said female Luer part with anexterior surface of said end of said stopper flush with a surroundingportion of said female Luer part.
 5. The medical connector of claim 4,wherein said skirt has an axially expansible and contractible portionbetween said annular seat and said stop surface.
 6. The medicalconnector of claim 5, wherein said skirt slidably contacts said femaleLuer part and said insert.
 7. The medical connector of claim 6, whereinsaid skirt includes a sealing portion which engages said female Luerpart and said insert.
 8. The medical connector of claim 1, wherein saidinsert and said female Luer part have mating portions of non-circularcross-section for non-rotatably positioning said insert in said femaleLuer part.
 9. The medical connector of claim 1, wherein said seal andsaid male Luer part have at least one mating groove and rib tonon-rotatably position said seal in said male Luer part.
 10. The medicalconnector of claim 1, wherein said female and male Luer parts haveabutting faces and exposed surfaces adjacent said faces, said exposedsurfaces having indicia which may be aligned at full open and closedpositions of the connector.
 11. The medical connector of claim 10,wherein said abutting faces extend in radial planes.
 12. The medicalconnector of claim 10, further comprising slidably engageable surfaceson said female and male Luer parts defining full open and closedpositions of said connector.
 13. The medical connector of claim 1,wherein said female Luer part and said seal have abutting radiallyextending surfaces.
 14. The medical connector of claim 13, wherein saidinsert and said seal have abutting radially extending surfaces.
 15. Themedical connector of claim 1, wherein said female and male Luer partsare connected by a snap fit.
 16. The medical connector of claim 15,wherein said snap fit connection of said male and female Luer partscauses compression of a peripheral portion of said seal.
 17. The medicalconnector of claim 1, wherein said female and male Luer parts and saidinsert are made of polycarbonate and said stopper and said seal are madeof silicone.
 18. An elastomeric stopper having an axially extendingskirt which includes a longitudinally expansible and contractibleportion and an integrally formed end, said end having a normally closedslit to provide a deformable opening to the interior of said skirt. 19.The stopper of claim 18, wherein said end has a first outside diameter,and said skirt includes a collar and a bellows having a second outsidediameter larger than said first outside diameter.
 20. The stopper ofclaim 19, wherein said skirt includes a cylindrical outer surface at asecond end.
 21. The stopper of claim 20, wherein said skirt includes aradially extending surface at said second end.
 22. The stopper of claim21, wherein said skirt is silicone elastomer.
 23. A medical connectorhaving a longitudinal axis and interconnected axially aligned relativelyrotatable male and female Luer parts forming a housing whereby relativerotation of said parts opens and closes a fluid flow path through saidconnector, said parts being configured for connection to external maleand female Luer flowlines; a flow conducting insert non-rotatablyaffixed in said female Luer part, said insert having an internal fluidpassageway extending from a first axially aligned end to a second end,said second end being offset from said axis, said insert having anaxially compressible section; a compressible seal in said male Luerpart, said seal abutting said second end of said insert and having aflow passageway extending between a first axially offset end at saidsecond end of said insert to an axially aligned second end, such thatsaid ends of said flow passageways in abutting ends of said insert andseal may be aligned to open said flow path; and an elastomeric stopperon said insert, said stopper having a swabbable end providing adeformable normally closed opening which may be opened by pushing saidswabbable end over said insert by an external male Luer received in saidfemale Luer part.
 24. The medical connector of claim 23, wherein saidaxially compressible section of said insert is corrugated.
 25. Themedical connector of claim 24 wherein in said insert includes a seatengageable with said second end of said skirt.
 26. The medical connectorof claim 25, wherein said corrugated section is proximate said seat.